510(k) K041421 ยท MQV Filler, Bone Void, Calcium Compound
NAME BONE VOID FILLER
| Applicant | Stryker Biotech, Hopkinton MA, US |
| Decision | Substantially Equivalent, Aug 26, 2004 |
| Received | May 28, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041421
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2006 | Stryker Biotech Calstrux (Previously known as TCP Putty)-
Absorbable Bone Void Filler, packaged in:
Catalog Number: 400-05: quantity-5cc
Catalog Number: 400-10: quantity 10cc
Catalog Number: 400-15: quantity 15cc Terminated |
MQV | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.